Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Surgery Clinical Trial

— DETPLUST  

Official title:

Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561478
• Other study ID #: 2021-A02415-36
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Cutting Edge SAS
• Contact: Line Bettinelli, OD
• Phone: 0619530701
• Email: line.bettinelli[@]cutting-edge.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patient older than 50 years old

• Patient requiring bilateral cataract surgery

• Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.

• Expected postoperative astigmatism = 0.75D diopter

• Corneal astigmatism =4D

• IOL spherical equivalent power requested between 15D and 25D

• Signed informed consent

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Non inclusion Criteria:

• Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.

• Amblyopia with a visual acuity potential of less than 5/10

• IOL power needed outside the spherical equivalent diopter range: 15 to 25D

• Difficulty for cooperation (distance from their home, general health condition)

• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)

• Irregular astigmatism

• Subject with postoperative astigmatism, expected > 0.75 D.

• Any ocular comorbidity

• History of ocular trauma or prior ocular surgery including refractive procedures

• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

• Patients with chronic uveitis

• Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions))

• Narrow anterior chambers (ACD = 2.5 mm)

• Any corneal pathology potentially affecting the topography (eg. Keratoconus),

• Monophthalma patients

• Phacodonesis

Exclusion criteria:

• Complicated surgery

• Inability to place the intraocular lens safely at the location planned

• Subjects with zonular laxity

• Postoperative endophthalmitis

Related Conditions & MeSH terms

• Cataract
• IOL
• Surgery

Intervention

Device:
• Implantation of Synthesis Plus IOL (control device)
Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
• Implantation of Synthesis Plus Toric IOL (investigational device)
Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

Locations

Country	Name	City	State
France	VISIS	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Cutting Edge SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCIVA at 66 cm	The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS	1 month
Secondary	Monocular UDVA	distance	1 month
Secondary	Monocular BCDVA	distance	1 month
Secondary	Monocular UIVA	66 cm	1 month
Secondary	Monocular DCIVA	66 cm	1 month
Secondary	Refraction	subjective	1 month
Secondary	Potential complications	postoperative	1 month
Secondary	Rotational stability	in degrees	Peroperatively, day 0, Month 1
Secondary	Subjective quality of vision	PROM	1 month